Back to search results

Zanidatamab Before Surgery for HER2-Positive Colon and Rectal Cancer

This study is testing zanidatamab before surgery for patients with HER2-positive colon or rectal cancer that is planned for curative treatment. Zanidatamab is a monoclonal antibody, a type of protein that can target specific cells, and it may help stop cancer cells from growing and spreading. To join, your colon or rectal cancer must be confirmed and be HER2-positive. Researchers want to see how well zanidatamab shrinks tumors before surgery and how safe it is. This study plans to enroll 38 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is not specified if it's a randomized or blinded study, or its phase.
What's involved
You would receive zanidatamab intravenously (through a vein) on day 1 of each cycle, undergo surgical removal of the tumor, and have observation. You would also have heart tests like echocardiography and MUGA scans.
Compensation
Not stated in the trial record.
Follow-up
The study measures tumor response at the time of surgical removal, and radiologic response at 6 and 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07405476

Zanidatamab Before Surgery for the Treatment of HER2 Positive Colon and Rectal Cancer in Patients Planned for Curative Intent Treatment

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~38 participants
Updated 2026-04-17 on ClinicalTrials.gov
What's tested:ZanidatamabResectionPatient ObservationEchocardiography TestMultigated Acquisition ScanEndoscopic Procedure

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Rate of Complete and Major Pathologic Regression (Cohort 1)
Measured over At time of surgical resection
+2 more outcomes measured

Conditions

Colon Carcinoma
Colorectal Carcinoma
Rectal Carcinoma
Stage I Colon Cancer AJCC v8
Stage I Colorectal Cancer AJCC v8
Stage I Rectal Cancer AJCC v8
Stage II Colon Cancer AJCC v8
Stage II Colorectal Cancer AJCC v8
Stage II Rectal Cancer AJCC v8
Stage III Colon Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8

Explore related trials

Colon CarcinomaRectal CarcinomaERBB2 GeneRAS Family Oncogene

Where it's being run

4 sites across 1 states
Georgia4

Study leadership

  • Olumide B. Gbolahan, MBBS, MSc · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Olumide B. Gbolahan, MBBS, MSc
[email protected]
404-778-1900
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Histologically or cytologically confirmed colon and/or rectal cancer planned for curative intent treatment at gastrointestinal clinics of Emory University's Winship Cancer Institute and collaborating centers
Tumors must be HER2+ve (human epidermal growth factor receptor 2 \[HER2\] overexpression 3+ immunohistochemistry \[IHC\] or 2+ by IHC and positive fluorescence in situ hybridization \[FISH\] or HER2 amplification by next generation sequencing)
Tumors must have RAS wildtype genotype
Radiologically measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Age ≥ 18 years
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 50%)
Platelet count \> 100,000 cells/ ul (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Hemoglobin \> 9g/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Absolute neutrophil count \> 1000 cells/dl (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Aspartate aminotransferase (AST) ≤ 3 × upper limit of normal (ULN) (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Alanine aminotransferase (ALT) ≤ 3 × ULN (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Total bilirubin ≤ 1.5 × ULN, or ≤ 3 × ULN for participants with Gilbert's disease (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Glomerular filtration rate (GFR) \> 60ml/min (based on creatine, and Cystatin C estimation where applicable) (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Adequate cardiac function with left ventricular ejection fraction of at least 50% (within 28 days of cycle 1 day 1, at the discretion of the investigator)
Females of child-bearing potential (FCBP) must have a negative serum or urine pregnancy test prior to starting therapy
FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and 3 months after completion of study drug administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions. This includes willingness to undergo mandatory blood sample draws for evaluation of correlatives
Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.
RAS mutation
MSI-H or mismatch repair deficient rectal cancer
Clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension or any history of symptomatic congestive heart failure (CHF). Participants with known myocardial infarction or unstable angina within 6 months prior to expected date of cycle 1 day 1 (C1D1) are also excluded. Previous anticancer therapy-related CHF must have been ≤ grade 1 at the time of occurrence and must have completely resolved
Participants receiving any other investigational agents or an investigational device within 28 days of administering the first dose of study drug
History of allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in study
Uncontrolled current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Exclusion

Participants with stage IV colon and rectal cancer even if curative intent resection is planned

What this trial measures

  • Rate of Complete and Major Pathologic Regression (Cohort 1)At time of surgical resection

    For colon cancer, will evaluate the rate of complete and major pathologic regression in the surgical specimen based on the modified Dworak grading system. Will be reported as a proportion, and 95% exact binomial confidence interval. Will be estimated using the Clopper-Pearson method.

  • Radiologic Response (Cohort 2)At 6 and 12 weeks

    Assessment will be by computed tomography chest, abdomen and magnetic resonance imaging of the rectum. Radiologic tumor response will be based on Response Evaluation Criteria in Solid Tumors 1.1. Will be reported as a proportion, and 95% exact binomial confidence interval. Will be estimated using the Clopper-Pearson method.

  • Tumor Regression Grades (Cohort 2)At time of surgical resection

    Will be assessed in those who undergo surgical resection.